At-Home Aligners: Why the FDA Stopped Byte and What It Means for Your Smile

The promise of aligners delivered to your doorstep has attracted millions of people. But Byte's recent FDA suspension reveals risks you need to know before trusting your smile to a mailbox.

The fall of a giant: What happened with Byte?

In October 2024, Dentsply Sirona voluntarily suspended sales of Byte, its at-home aligner system. The reason? The FDA identified that the patient onboarding process did not adequately screen out contraindicated cases.

In other words, people who should never have received these aligners were treated - sometimes with serious consequences.

This decision followed concerning "medical device reports" and discussions with U.S. health authorities. On December 23, 2024, the FDA officially classified Byte aligners as a Class II recall.

The real risks of unsupervised aligners

Documented problems include:

• Jaw misalignment - Teeth move too fast or in the wrong direction
• Cracked or broken teeth - Excessive pressure can damage enamel
• Gum recession - Gums recede, exposing tooth roots
• New bite problems - Gaps or crowding that didn't exist before
• Worsening periodontal disease - Undetected pre-existing conditions that get worse

The fundamental problem? These systems rely on self-assessments and photos taken by the patient. Without a thorough clinical examination, it's impossible to detect:

• Active periodontal disease
• Bone loss
• Hidden cavities
• TMJ problems
• Unsuitable bone structure

SmileDirectClub: The warning that should have been heeded

Byte is not an isolated case. In November 2023, SmileDirectClub declared bankruptcy with nearly $900 million in debt. The company tried to restructure unsuccessfully before being liquidated in January 2024.

Thousands of patients were left:

• With unfinished treatments
• Without recourse for refunds
• With dental problems created by the treatment

What the AAO recommends

The American Association of Orthodontists (AAO), the world's largest orthodontic association, is clear:

"Orthodontic treatment is not a quick fix. We recommend working with a qualified orthodontist rather than pursuing at-home solutions independently."

The AAO emphasizes that orthodontists complete more than 3,700 hours of specialized training beyond dental school - expertise that no app or online questionnaire can replace.

Why professional supervision makes all the difference

The apparent savings can be costly

At-home aligners seem economical ($1,500-2,500), but hidden costs add up:

• Retreatments needed with a professional after failure
• Damage corrections caused by treatment
• Time lost - sometimes years of ineffective treatment
• No recourse if the company goes bankrupt (like SDC)

Professional treatment with Invisalign or braces represents a larger initial investment, but includes:

• A complete diagnosis
• Personalized follow-up
• Unlimited adjustments
• Guaranteed results
• An accountable professional

Our approach at the Orthodontic Centre

At Dr. David Benguira's Orthodontic Centre, we use state-of-the-art 3D imaging and intraoral scanners to create truly personalized treatment plans.

Every patient benefits from:

• A thorough clinical examination
• Complete radiographic analysis
• A customized treatment plan
• Regular follow-up with adjustment options
• The expertise of a specialized orthodontist

We offer several options tailored to your needs and budget, including Invisalign, SPARK, traditional and lingual orthodontics.